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Amber is in charge of registering new subsidiaries and medical products in China and foreign markets and oversees complete product life cycle quality systems.

 

Over two decades with multinational corporations and regulatory committees in the MedTech space have made Amber an expert on regulations regarding the management of drugs and medical devices in China and the United States as well as international harmonisation organisations.

 

Prior to Genesis, Amber made her mark at MSD China (默沙东公司), Medtronic China (美敦力公司), and most recently at Smith & Nephew Medical Shanghai Ltd (施乐辉公司) where, in her role as VP of GC Regulatory and Quality Assurance, she led department strategy and direction and managed local and global regulatory agency relationships.

 

Amber holds a Bachelor of Science degree in Pharmacology from Beijing University and received her master’s degree in Business Management from the University of International Business and Economics.

 

2017 to present Drug Information Association (DIA USA)
Member, Advisory Council of DIA China
2016 to present Asian Harmonization Working Party (AHWP)
Representative of China Device Industry
2014 to present China Society for Drug Regulation (CSDR)
Member, Special Committee for Medical Device
2018 to 2020 European Union Chamber of Commerce in China (EUCCC)
Vice Chair, Healthcare Equipment Working Group
2017 to 2020 ApecMED
Vice Chair of China CoE
2016 to 2017 European Union Chamber of Commerce in China
Chair, Healthcare Equipment Working Group
2005 to 2019 Regulatory Affairs Professionals Society USA
Member
2005 to 2008 China Association of Medical Device Industry (CAMDI)
Vice Chair, Surgical Implant Committee
2002 to 2005 Drug Information Association USA
Member

 

Position
VP, Regulatory Affairs and Quality Assurance